U.S. patent number 5,462,560 [Application Number 08/134,263] was granted by the patent office on 1995-10-31 for double needle ligature device.
This patent grant is currently assigned to Tahoe Surgical Instruments. Invention is credited to Jon A. Stevens.
United States Patent |
5,462,560 |
Stevens |
October 31, 1995 |
Double needle ligature device
Abstract
A double needle ligature device for efficiently creating a loop
suture for closing wounds, such as trocar wounds. The device
preferrably includes a double rod-in-needle assembly to ensure that
the suture is positively held in place during needle
retraction.
Inventors: |
Stevens; Jon A. (Hayward,
CA) |
Assignee: |
Tahoe Surgical Instruments
(N/A)
|
Family
ID: |
22462539 |
Appl.
No.: |
08/134,263 |
Filed: |
October 8, 1993 |
Current U.S.
Class: |
606/144; 606/127;
606/139; 606/148; 606/169; 606/222 |
Current CPC
Class: |
A61B
17/06109 (20130101); A61B 17/12009 (20130101); A61B
17/12013 (20130101); A61B 17/0485 (20130101); A61B
2017/0472 (20130101); A61B 2017/061 (20130101) |
Current International
Class: |
A61B
17/12 (20060101); A61B 17/06 (20060101); A61B
17/04 (20060101); A61B 017/00 () |
Field of
Search: |
;606/1,139,144,145,147,148,150,167,222-227,170,181,183-187,189
;604/173,267,268,272 ;112/169,80.03 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
|
|
|
|
|
|
|
404226643 |
|
Aug 1992 |
|
JP |
|
0242110 |
|
Nov 1925 |
|
GB |
|
0639845 |
|
Jul 1950 |
|
GB |
|
Other References
Brochure--Ideas for Medicine Inc., Grice Suture Needle..
|
Primary Examiner: Aschenbrenner; Peter A.
Assistant Examiner: Schmidt; Jeffrey A.
Attorney, Agent or Firm: Bengtsson; W. Patrick
Claims
What is claimed is:
1. A ligature device including:
(1) a needle assembly comprising
(a) needle support means for holding
needles;
(b) first and second hollow needles, each of said needles having a
shaft, a proximal end, a distal end, and a sharpened distal tip,
said needles being mounted on said needle support means at their
proximal ends and extending substantially parallel to one another
from said support means; and
(c) first suture support means for slidably supporting a suture
comprising a transverse passage across said shaft of said first
needle; and
(2) a rod assembly comprising
(a) rod support means for holding rods;
(b) first and second rods, each of said rods having a shaft, a
proximal end, and a distal end, said rods being mounted on said rod
support means at their proximal ends and extending substantially
parallel to one another from said rod support means,
(c) a filament loop, positioned at said distal end of said second
rod;
said rod assembly being slidably engaged with said needle assembly
such that said first and second rods are positioned within said
first and second needles respectively and said rod assembly is
movable with respect to said needle assembly from a rod extended
position to a rod retracted position, and, when said rod assembly
is in said rod extended position, said distal end of said first rod
extends past said transverse passage and said filament loop extends
past said distal end of said second needle.
2. A ligature device according to claim 1 further comprising
biasing means positioned between said needle support means and said
rod support means for urging said needle and rod assemblies toward
said rod retracted position.
3. A ligature device according to claim 2 wherein said biasing
means comprises a pair of tensioned metal or plastic strips.
4. A ligature device according to claim 1 wherein said needle and
rod support means each comprise a rectangularly shaped bar, and
said device further comprises biasing means for urging said needle
and rod assemblies toward said rod retracted position, said biasing
means comprising a pair of tensioned metal or plastic strips
extending between said bars.
5. A ligature device according to claim 1 further comprising a
releasable lock for locking said needle and rod assemblies together
in said rod extended position.
6. A ligature device according to claim 1 wherein said first hollow
needle is longer than said second hollow needle.
7. A ligature device including:
(1) a needle assembly comprising first and second hollow needles
mounted on a first handle, each of said needles having a shaft, a
proximal end, a distal end, said needles being mounted on said
first handle at their proximal ends and extending substantially
parallel to one another from said first handle, and said first
needle having a transverse passage across the shaft thereof;
and
(2) a rod assembly comprising first and second rods mounted on a
second handle, each of said rods having a shaft, a proximal end,
and a distal end, said rods being mounted on said second handle at
their proximal ends and extending substantially parallel to one
another from said second handle, a loop filament for capturing a
suture extending from said distal end of said second rod;
said rod assembly being slidably engaged with said needle assembly
such that said first and second rods are positioned within said
first and second needles respectively and said rod assembly is
movable with respect to said needle assembly from a rod extended
position to a rod retracted position, and, when said rod assembly
is in said rod extended position, said distal end of said first rod
extends past said transverse passage and said loop extends past
said distal end of said second needle.
8. A ligature device according to claim 7 further comprising
biasing means for urging said needle and rod assemblies toward said
rod retracted position.
9. A ligature device according to claim 7 further comprising a
releasable lock for locking said needle and rod assemblies together
in said rod extended position.
Description
FIELD OF THE INVENTION
This invention relates to medical devices used to close surgical
wounds, and in particular to a fixed double-needle ligature device
particularly useful for creating circumferential ligatures as are
needed in, for example, laparoscopic surgery.
BACKGROUND OF THE INVENTION
During laparoscopic surgery, the surgeon often creates a trocar
wound; a round hole in tissue that exposes the inside of a body
cavity, such as the abdomen. Once the surgery is completed, the
trocar wound must be closed. The difficulty lies in creating a loop
suture to complete circumferential ligatures around such wounds.
More precisely, it is difficult to loop a suture into a body cavity
on one side of a wound and get the suture to exit the body cavity
on the other side of the wound so the suture ends can be tied to
close the trocar wound.
A prior art solution involves using a single needle device, such as
the Grice Suture Needle, marketed by Ideas for Medicine, Inc. In
this prior art device, the needle is first forced through the
tissue while carrying the end of a suture into the body cavity. The
needle is then retracted (leaving the end of the suture in the
body) and is inserted again on the other side of the wound. A
grasper is used to guide the end of the suture to the tip of the
reinserted needle. The needle includes a suture holding indentation
near its tip in which the suture is secured as the needle is again
withdrawn. The suture is then tied to close the wound.
While the prior art procedure is adequate for wound closure, the
single+needle procedure includes sequential insertions of the
needle into the body cavity, requiring significant surgical skill
and manipulation. The sequential process also takes significant
time to complete. Further, loss of the suture end from the needle
as it is withdrawn is a problem.
It would therefore be advantageous to have a device which could
create a loop around a wound, such as a trocar wound, in a shorter
time or with less surgical manipulation, in a manner which
minimizes the chance of inadvertently losing hold of the suture
during needle withdrawal.
SUMMARY OF THE INVENTION
In order to address these concerns, the present invention is
directed to a device which includes two needles mounted
substantially parallel and separated by a distance greater than the
diameter of the wound to be closed. Each needle includes a means
for securing the suture to the needle.
In a preferred form of the invention, the ligature device comprises
two main parts: a needle assembly and a rod assembly. In this
embodiment, the needle assembly is made up of a needle support
means (usually a plastic rectangularly shaped bar) for holding
needles; first and second hollow needles, each of the needles
having a shaft, a proximal end, a distal end, and a sharpened
distal tip, and the needles are mounted on the needle support means
at their proximal ends. The needles extend substantially parallel
to one another from the support means. The needle assembly also
includes a first suture support means for slidably supporting a
suture, the support means comprising a transverse passage, e.g. a
hole, across the shaft of the first needle. The rod assembly of
this embodiment includes rod support means for holding rods (again
such as a rectangular plastic bar), first and second rods, each of
the rods having a shaft, a proximal end, and a distal end, the rods
being mounted on the rod support means at their proximal ends. Like
the needles, the rods extend substantially parallel to one another
from the rod support means. At the distal end of the second rod is
positioned a second suture support means for slidably supporting a
suture. Preferrably this support means is a polymeric or wire
filament in the form of a loop.
An important feature of the invention is that the rod assembly is
slidably engaged with the needle assembly such that the first and
second rods are positioned within the first and second needles and
the rod assembly is movable with respect to the needle assembly
from a rod extended position to a rod retracted position. When the
rod assembly is in the rod extended position, the distal end of the
first rod extends past the transverse passage in the first needle.
At the same time, this configuration allows the second suture
support means (i.e. the loop) to extend past the distal end of the
second needle.
By using the structures disclosed herein, the suture loop necessary
for closing a trocar type wound can be quickly created by ensuring
that the suture is carefully and firmly held within the needles of
the device.
BRIEF DESCRIPTION OF THE DRAWINGS
The invention will be better understood by reference to the
appended drawings of which:
FIG. 1 is a side view of the preferred embodiment of the invention
in its relaxed or rod retracted position while inserted into a body
cavity;
FIG. 2 is a side view of the device of FIG. 1 in a compressed or
rod extended position;
FIG. 3 is a detailed side view showing the feed needle and feed
rod;
FIGS. 4(a) and 4(b) show the end of the feed needle and feed rod,
detailing the primed position of the suture; and
FIG. 5 shows the device during retraction of the suture through the
outlet needle.
FIGS. 6(a) through 6(c) show an alternative embodiment of the
invention.
DETAILED DESCRIPTION OF THE INVENTION
The apparatus of the invention and the method by which it is used
is shown in detail in FIGS. 1 through 5.
The preferred embodiment of the invention is shown in FIG. 1,
designated in its entirety by reference number 70. Device 70
includes two hollow needles, suture feed needle 72 and suture
retractor needle 74. A needle separation bar (and handle) 76 holds
needles 72 and 74 a distance apart and substantially parallel to
each other. Feed needle 72 includes aligned holes 80 and 82 near
its tip 84. Needle tips 84 on each of needles 72 and 74 have angled
cutting ends for easier insertion through tissue. While FIG. 2
shows needle 74 being shorter than the feed needle 72, this is not
necessary. However, to date it appears that the uneven length of
the needles facilitates the ability to secure the fascia in a
proper technical form.
A rod positioner bar 90 secures suture feed rod 92 to retractor rod
94. Rods 92 and 94 are held parallel to each other and are spaced
the same distance apart as the needles 72 and 74. Rod 92 inserts
into feed needle 72 and rod 94 inserts into loop needle 74.
A suture engaging loop 96 is attached to the end of rod 94. The
loop is formed from a filament of metal or plastic, such as
polyethylene. Any material which will form the loop and which is
inert with respect to tissue can be used.
In order to minimize the degree of manipulation of the device by
the surgeon, the degree of insertion of rods 92 and 94 into the
needles 72 and 74 can advantageously be controlled by a biasing
mechanism 100. Biasing mechanism 100 connects needle handle or bar
76 to bar 90 to provide a flexing motion. In a preferred
embodiment, biasing mechanism 100 is formed from plastic or metal
tensioners to create a spring tension when forced out of its
relaxed state. In its relaxed state, as shown in FIG. 1, biasing
mechanism 100 holds bars 76 and 90 apart by such a distance that
the end of rod 92 will not pass holes 80 and 82 in needle 72, and
loop 96 does not extend from the end of needle 74.
Biasing mechanism 100 is closed by squeezing bars 76 and 90
together, as shown in FIG. 2. When bars 76 and 90 meet, feed rod 92
is forced beyond holes 80 and 82 and loop 96 extends beyond the tip
of loop needle 74. Biasing mechanism 100 flexes as bars 76 and 90
are squeezed together. Biasing mechanism 100 supplies a spring
pressure when compressed such that when the bars 76 and 90 are
released, the device will return to the relaxed state shown in FIG.
1.
Other types of biasing mechanisms well known to those in the art
may be substituted for the mechanism 100. For example, a simple
leaf spring mechanism mounted between bars 76 and 90 could be used,
as shown in FIGS. 6(a) through 6(c).
Latching mechanism 102 mounted or formed integrally with bar 76
allows bars 76 and 90 to be securely attached together, as shown in
FIG. 2. Latch 102 allows the surgeon to lock biasing mechanism 100
in its compressed position. The surgeon may want to let go of the
device while it is inserted into the body cavity without the spring
force the biasing mechanism 100 returning it to a relaxed
position.
The end of feed rod 92 is notched, as shown in FIG. 3. Notch 98 is
in the same direction as the inline holes 80 and 82 so as to
prevent the suture passing through the holes from being cut by feed
rod 92 passing holes 80 and 82.
To close a wound, the strategy shown in FIGS. 4(a), 4(b) and 5 is
employed. As shown in FIG. 4(a), a suture end 110 is first threaded
through holes 80 and 82. The suture is then "primed" by squeezing
bars 76 and 90 together until rod 92 forces the suture slightly
past holes 80 and 82. Bars 76 and 90 are then released whereby the
suture is left in this "primed" position as shown in FIG. 4(b). In
its "primed" position, the suture is securely held such that upon
insertion of device 70 into the body cavity, the suture will not
slip back through holes 80 and 82.
Device 70 is then inserted through a cavity wall so that the ends
of needles 72 and 74 penetrate the wall of the cavity, one on each
side of the wound 10, as shown in FIG. 1.
In a preferred method of use, the amount of cavity wall used to
close the trocar wound can be advantageously increased by inserting
the longer feed needle 72 into the tissue first at approximately a
15.degree. angle. The device is then rotated slightly to a position
such that needles 72 and 74 are inserted perpendicular to the skin
surface adjacent the wound.
Upon insertion of device 70, suture end 110 will be free inside the
body cavity. The surgeon then compresses bar 90 and bar 76 such
that loop 96 extends beyond the tip of needle 74, as shown in FIG.
2. Rod 92 passes holes 80 and 82 so as to hold a portion of the
suture within feed needle 72 secure. A suture grasper (not shown)
is then used to grasp suture end 110 and feed it through loop 96.
Bars 90 and 76 are subsequently decompressed to withdraw loop 96
inside loop needle 74, as shown in FIG. 5. Suture end 110 is
securely held in place by loop 96. Needles 72 and 74 are then
removed from the body, thereby withdrawing the suture held by the
loop 96.
As device 70 is removed from the body and the tension increases,
the portion of the suture in needle 72 will be pulled taut before
the tension is great enough to dislodge the end of the suture from
loop 96. Thereafter, the suture will slide freely through holes 80
and 82 to supply a sufficient length of suture to permit removal of
the suture from the body.
After the device is removed from the body the surgeon can remove
the suture from loop 96, allowing suture ends 96 to be tied
together.
While the invention has been described with reference to the
closure of trocar wounds arising from laparascopic surgery, those
skilled in the art will recognize that the invention will be useful
for any procedure requiring ligature of a major vessel or organ.
Such procedures would include, for example, a bladder suspension, a
uterine neck for a hysterectomy, an apendectomy or a laporascopic
bowel resection. An alternative embodiment of the above-described
invention is shown in FIGS. 6(a) through 6(c). In this embodiment,
a leaf-spring 101 is used to bias bars 76 and 90. Indents 120 are
also formed on needle separation bar (handle) 76.
* * * * *